Surprising nearly everyone, FDA has reopened a long dormant discussion regarding the meaning of the term “natural” in the labeling of food. Today’s Federal Register contains a notice from FDA that the agency has officially opened a docket to receive information and public comment on the use of the term “natural” on food labeling, including foods that are genetically engineered or that contain genetically engineered ingredients.
Despite repeated requests in Citizen Petitions and various courts for FDA to weigh in on the interpretation of, and limits on, “natural” claims on food products, very few observers expected FDA to formally reopen the issue at this time. Ready or not, however, FDA has asked for input, and an opportunity has arrived for interested parties to share their perspectives with FDA. This notice presents a rare and unanticipated opportunity to influence an area of food labeling that has been largely closed to new thinking for many years.
Notably, this action creates a space for open discussion of the key issues regarding the meaning of “natural” in the context of food labeling, but it does not promise further agency action. FDA will certainly receive a lot of feedback in response to this request, but it is difficult to envision a circumstance where FDA tackles the issues in a formal regulatory action in the near future.
Background: “Natural” History
For over 20 years, FDA policy concerning the use of “natural” in the context of food labeling has been to evaluate the use on a case-by-case basis in accordance with broad guidelines regarding when “natural” might be misleading to consumers. The general policy was outlined during a prior effort to define the term “natural.” At that time, in seeking comments regarding an appropriate definition, the Agency noted that it generally interprets “natural” to mean that nothing artificial or synthetic has been added or included in a product that would not normally be expected to be present.
Ultimately, FDA decided not to establish a definition for “natural” and to maintain its policy not to expressly restrict the use of the term in most cases. Absent a formal definition, “natural” became one of the most popular claims on food labels and in advertising, and its widespread use spawned a practice specialty within the plaintiff trial bar of suing companies making “natural” claims. Until today’s notice and request for comment, FDA had not indicated that it had any immediate intention to revisit “natural” food labeling claims.
FDA may now be ready to change from an ad-hoc policy with loose guidelines, to a more formal definition of “natural”. FDA also appears to indicate that any formal definition of “natural” will likely require FDA to address difficult issues, including issues related to the labeling of genetically engineered foods.
What’s Next? The “Natural” Progression
Having observed and advised on “natural” food labeling issues for over 20 years, we are excited to see movement in the area, but we remain guarded in asserting any opinion that definitive agency action will ensue. Similar to the situation when FDA started down this road before, FDA is operating under significant resource constraints, making prioritization of this issue difficult in the face of other pressing agency concerns. Additionally, defining “natural” may be more complicated an issue than it was previously, when due to the complexity of the issue, stakeholder comments failed to provide FDA any “specific direction to follow for developing a definition regarding the use of the term ‘natural’.” Issues related to genetic engineering and food production methods have arguably made the issue more difficult than ever.
